DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 2-10, 14, and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/04/2026.
Applicant’s election without traverse of Species E, Figs. 28-39, a flow rate control device with one balloon and a flow port catheter with a distal tip extending beyond a distal end of the balloon in the reply filed on 05/04/2026 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sanchez Garcia (US 20180318560 A1), herein referenced to as “Sanchez Garcia”.
Claim 1
Sanchez Garcia discloses: An endovascular occlusion device 10 (see Figs. 1-5A, [0028]) comprising: a first balloon 12 (see Figs. 1-5A, [0028]) having a distal end distal end of 12 (see Figs. 1-5A), a proximal end proximal end of 12 (see Figs. 1-5A), and a lumen 12b + P (see Figs. 1-5A, [0029], inflation lumen) extending therebetween, the first balloon 12 having a deflated state (see [0028]-[0029], has an inflated and a deflated condition) and an inflated state (see Fig. 1, [0028]), wherein the first balloon 12 in the inflated state (see Fig. 1) is configured to contact an inner wall of a vasculature; and a second balloon 18 (see Figs. 1-5A, [0031]) having a distal end distal end of 18 (see Figs. 1-5A), a proximal end proximal end of 18 (see Figs. 1-5A), and a lumen L (see Figs. 1-5A, [0032]) extending therebetween, the second balloon 18 having a deflated state (see [0032], selectively inflating) and an inflated state (see [0032], has a deflated state and a state it can be inflated to, hence an inflated state), wherein the second balloon 18 in the inflated state (see Fig. 2, [0033]-[0034], can block passage P which blocks blood flow through the lumen of 12) is configured to restrict blood flow through the lumen P of the first balloon 12 and the second balloon (see [0033]-[0034], when not inflated it will not block fluid flow) in the deflated state is configured to permit blood flow through the lumen P of the first balloon 12.
The language, "wherein the first balloon in the inflated state is configured to contact an inner wall of a vasculature," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sanchez Garcia meets the structural limitations of the claim, and is capable of the balloon 12 inflating to contact the walls of the vessel to stabilize and not further move, in order to mimic natural flow of blood during an operation in which an associated valve is incapacitated as a result of the procedure (see [0034]).
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 15
Sanchez Garcia discloses: The endovascular occlusion device of claim 1, see 102 rejection above. Sanchez Garcia further teaches: further comprising: a delivery sheath tubular, flexible sheath or cover (see [0028], over 12a) configured to surround and receive the first 12 and second balloons 18 (the sheath surrounds 12, which surrounds 18, hence the sheath surrounds both 12 and 18).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez Garcia in view of Shoup et al (US 5591129 A), herein referenced to as “Shoup”.
Claim 11
Sanchez Garcia discloses: The endovascular occlusion device of claim 1, see 102 rejection above. Sanchez Garcia does not explicitly disclose: further comprising: a handle operable coupled to the first and second balloons.
However, Shoup in a similar field of invention teaches an endovascular device 10 (see Figs. 7-17 and 23-24) with a first balloon 16 (see Figs. 7-17 and 23-24) and a second balloon 70 (see Figs. 23-24) within the first balloon 16. Shoup further teaches: further comprising: a handle 54 (see Figs. 16-17, col. 2, lines 35-46, advancing the catheter, col. 7, lines 48-65) operable coupled to the first 16 and second balloons 70 (44 is attached to 70 to control the movement of 70 within the distal end of 16, while 12 is connected to the handle and allows for control of 16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sanchez Garcia to incorporate the teachings of Shoup and teach an endovascular device with a handle operable coupled to the first and second balloons. Motivation for such can be found in Shoup as this allows for selective control of the perfusion and altering of the amount of perfusion of the catheter from outside the body (see col. 7, lines 47-67, col. 8, lines 1-6).
Claim 12
The combination of Sanchez Garcia and Shoup teaches: The endovascular occlusion device of claim 11, see 103 rejection above. Shoup further teaches: further comprising: a sheath 12 (see Figs. 7-17, col. 4, lines 46-57, col. 6, lines 45-54) having a proximal end proximal end of 12 attached to the handle (see Figs. 7-17, col. 2, lines 35-46, advancing the catheter, col. 7, lines 48-65), a distal end distal end of 12 attached to 16 (see Figs. 7-17), and a lumen the lumen of 12 (see Figs. 7-17) extending therebetween, the proximal end proximal end of 12 attached to the handle of the sheath 12 being operably coupled to the handle 54 and the distal end distal end of 12 attached to 16 of the sheath 12 being operably coupled (see Figs. 7-17 and 23-24, the sheath controls the relative positions of 16 and 70 by moving 16) to the first 16 and second balloons 70.
Claim 13
The combination of Sanchez Garcia and Shoup teaches: The endovascular occlusion device of claim 12, see 103 rejection above. Shoup further teaches: wherein the sheath 12 includes a plurality of lumens (see Figs. 7-8 and 23-24, 12 has several lumens, and has additional ones for 70 as 70 has an inflatable lumen that extends through 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cox et al (US 7087039 B1) teaches balloon perfusion catheter with a balloon blocking channels
Kutscher et al (US 20050209674 A1) teaches balloon assembly with an inner balloon selectively blocking perfusion outlets (see Figs. 63A-63C)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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